FDA offers guidance to protect against food supply attacks
The U.S. Food and Drug Administration (FDA) has released the first of three draft guidance documents designed to help food manufacturers protect their food products from intentional adulteration.
The U.S. Food and Drug Administration (FDA) has released the first of three draft guidance documents designed to help food manufacturers protect their food products from intentional adulteration. As a part of the Food Safety Modernization Act, the agency released a final rule in 2016 designed to address hazards that may be intentionally introduced to foods. These include acts of terrorism with the intent to cause wide-spread harm to public health. Unlike the other FSMA rules that address specific foods or hazards, the Intentional Adulteration (IA) rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration.
With the goal of equipping industry with the information and tools needed to meet the first implementation date of July 2019, the FDA has published the first of three guidance documents. The first installment focuses on the components of the food defense plan; how to conduct vulnerability assessments using key activity type method and how to identify and implement mitigation strategies and food defense monitoring requirements.
“This is new regulatory territory for both the FDA and industry,” wrote FDA Commissioner Scott Gottlieb in a statement on the agency’s website. “We’ve engaged directly with stakeholders while drafting this guidance to understand their perspectives and any concerns they have about complying with this rule. We’ve listened to their valuable feedback. Much of that feedback is reflected in the draft guidance we’re releasing today, as well as in the next two parts of the guidance.”
The second and third installments are expected to be released later this year. In the second draft guidance, the agency will focus on a vulnerability assessment approach that can be more tailored to a facility. The FDA will also provide guidance on training requirements for a food facility’s employees. In the third guidance, the FDA will provide greater detail on how to take corrective action; how to verify that a facility’s system is working; food defense plan reanalysis requirements; and record-keeping requirements.